There is a considerable number of patients with advanced cancer who could potentially benefit from biomarker-associated therapy. Philip Beer, Chief Scientific Officer at Step Pharma, explored how we can use genomics to accelerate drug development and improve the treatment of patients suffering from cancer.
According to recent research, approximately 5% of drugs that enter clinical development are approved for patient use. Beer suggested that by leveraging genomic technology, scientists can match patients with appropriate treatments and power clinical trials. Some attribute this high failure rate to institutional reasons as well as scientific ones, reiterating that this problem is well-known and widespread. Beer commented that economic analysis shows that it is cheaper to develop precision oncology drugs than for non-precision oncology.
Data from the GENIE dataset showed the diverse genetic nature of solid tumours in colorectal and breast cancers, which makes it complicated to figure out the exact cancer drivers and how to treat cancer. Therefore, reducing heterogeneity through genomic biomarkers is vital for treating solid tumours.
To achieve this, Beer suggested that scientists and researchers move away from the current low-efficiency model used in clinical trials for biomarker testing. Assay testing can find all the biomarkers in one go in a screened population was proposed by Beer as a technique that should be conducted in the clinical phase to accelerate drug development. He said: “If you can collect clinical outcome data from these cohorts, you can begin to build knowledge bases and work out how the genomics interact with clinical outcomes as well as find other biomarkers of response.”
The existing healthcare model is transactional rather than knowledge based. The knowledge gap between academics, commercial bodies, and the healthcare systems means the technology is not fully understood by all parties. However, a collaborative approach to adopting genomics technologies in socialised healthcare systems could help solve this. Beer highlighted a white paper published by the British In Vitro Association and Charles River that examines how to expedite the delivery of genomic medicine and efficiently implement technologies into public healthcare systems. The COVID-19 pandemic showed that it is possible to accelerate moving testing to clinical care and therapeutic development.
Regulatory challenges make it difficult for companies to navigate approval processes, while data protection laws like GDPR and IVDR regulations in the EU slow down the rollout of new diagnostics. IVDR, in particular, has caused significant delays in precision oncology trials, often pushing them back by 6-12 months. Funding is another major hurdle because there is no straightforward model for reimbursing genomic testing.
There needs to be a change in policy to foster collaboration between industry, academia, and healthcare players. Other strategies like horizon scanning should be used to track upcoming genomic biomarkers and implement them into testing. Beer also posited that establishing national genomic testing programs to facilitate patients’ access to testing is crucial.
In summary, Beer proposed effective solutions for integrating genomic information in clinical practice. He highlighted the need for policy changes to support genomic medicine, including better regulatory guidance, data protection clarity, and funding for genomic testing.
